System for prevention of fraud in accounting for utilization of medical items

ABSTRACT

At the time of manufacture of medical items that are to be consumed during patient care, a unique identification number is assigned to each item and the number is encoded in an RFID tag attached to the item. The manufacturer registers the unique identification number for each individual medical item in a Unique Device Identification (UDI) Serialized Tracking Database. The UDI Serialized Tracking Database maps each unique identification number to each item&#39;s UDI number that has been assigned by the Food and Drug Administration. As each item is consumed during medical treatment and its cost is billed to payers, the unique identification number of the item is reported and verified. This provides for detection of certain types of fraud in the dispensing of medical items by validating that necessary supplies were actually used during patient care.

RELATED APPLICATIONS

This application claims priority to as a continuation-in-part of U.S.nonprovisional patent application Ser. No. 14/504,859, filed Oct. 2,2014, titled “System for Sensing and Recording Consumption of MedicalItems During Medical Procedure,” U.S. nonprovisional patent applicationSer. No. 14/587,424, filed Dec. 31, 2014, titled “System for Sensing andRecording Information Regarding Medical Items in a Medical Facility,”and U.S. provisional patent application Ser. No. 62/422,295, filed Nov.15, 2016, titled “System for Prevention of Fraud in Accounting forUtilization of Medical Items,” the entire contents of which areincorporated herein by reference.

FIELD

This invention relates to the field of medical item inventorymanagement. More particularly, this invention relates to a system fordetecting fraud in the reporting of usage of medial items in thetreatment of medical patients.

BACKGROUND

The use of medical supplies and sterile medical devices in the provisionof health care services is one of the most significant expenses incurredby most health care facilities. Depending upon the nature and complexityof the medical procedure being performed, a large number of supply itemsmay be used during a medical procedure and, given the priorities ofmedical personnel involved in the procedure, the ability to track thesupplies, gather data about supply utilization and consumption, andrecord that data in a useable format can be especially difficult. Whilehospitals and other health care facilities may have sophisticatedinformation systems related to supply inventory management andprocedure-based supply requirements, such systems are not able toprovide consistent data analysis of supply utilization and optimizationif the usage data is not recorded diligently.

If accurate information about the consumption of supplies, devices andinstruments during a medical procedure is not captured, then the abilityto identify savings opportunities or to accurately bill for all consumedsupply items is lost. It is difficult to insure that this logging stepis performed accurately and consistently, since the medical personnelare primarily concerned with insuring the success of the medicalprocedure. Often, the medical personnel do not have time during theprocedure to manually log information into a computer for used itemsthat do not include barcodes, or to scan the barcodes of used items thathave barcodes. As a result, much of the information winds up being lostduring the turnover of the medical procedure room from one case toanother. Another problem with inaccurately recording usage informationis the possibility of erroneously charging for items that were not used,which can raise regulatory issues.

The Food and Drug Administration (FDA) has established a unique deviceidentification (UDI) system to accurately identify medical devicesthrough the course of their distribution and use. Through implementationof the UDI, the FDA aims to improve patient safety, modernize devicepost-market surveillance, and facilitate medical device innovation.

A UDI is a unique numeric or alphanumeric code that consists of twoparts: a device identifier (DI) and a production identifier (PI). A DIis a mandatory fixed portion of a UDI that identifies the device labelerand the specific version or model of a device. A PI is a conditional,variable portion of a UDI that contains item-specific information, suchas the lot or batch number within which a device was manufactured, theserial number and expiration date of a specific device, and the datethat a specific device was manufactured. Each UDI is provided in aplain-text version and in a form that uses automatic identification anddata capture (AIDC) technology. AIDC technology is any technology thatconveys the UDI or the DI of a device in a form that can be entered intoan electronic patient record or other computer system via an automatedprocess.

For many products, the PI contains only a lot or batch number. If twentyproducts having the same DI (e.g. 2.4 mm locking screws or disposablescalpels) are manufactured in the same lot/batch, all twenty productswill have the same lot/batch number. If the PI includes only a lot orbatch number, it is not possible to differentiate between specificindividual devices within the same lot/batch.

As part of the UDI registration process, device labelers must submitcertain information about each medical device to the FDA's Global UniqueDevice Identification Database (GUDID). The current version of the GUDIDis comparable to an online phone book. It allows a user to search for aparticular DI and download limited device identification information,which may include characteristics of the product, such as whether itcontains latex. Currently, registration of a product in the GUDID is aone-time event, and the submitted device information does not include PIinformation. Following the one-time registration process, dozens ofproduction lots that include potentially millions of products can bemanufactured with no update to the GUDID. These millions of medicaldevices are distributed into the medical care system with no uniquedevice identification that would allow for effective tracking ofspecific devices.

Currently, Medicare fraud wastes significant amounts of money, resultingin higher health care costs and taxes for everyone. Embodiments of theinvention described herein provide for truly unique deviceidentification to facilitate effective device tracking, thereby enablingdetection and reduction of Medicare fraud committed by medical providersand suppliers.

SUMMARY

In one aspect, embodiments of the invention use Radio FrequencyIdentification (RFID) tags to provide the following general functions:(1) identifying medical items or other resources that enter a room orother space in a medical facility; (2) determining where those medicalitems or other resources came from; and (3) determining whether thosemedical items or other resources were consumed during a medicalprocedure performed in the room or space.

In preferred embodiments of the present invention, each item pulled foruse during a particular medical procedure in accordance with the Bill ofMaterials (BOM) for the procedure includes an RFID tag affixed to theitem or the item's outer packaging. These RFID tags contain appropriateinventory information regarding each item as maintained in the inventorycontrol system and the Operating Room Information System (ORIS). Eachindividual item that might be used can be tracked through use of theRFID tags and appropriate RFID reader technology.

In preferred embodiments, each Operating Room (OR) or other procedureroom has a shielded enclosure with multiple RFID antennas disposedinside. Preferably, a waste bin or receptacle is disposed in theshielded enclosure. This shielded enclosure and an RFID reader connectedto the antennas may be conveniently located near the location where thesterile medical supplies are typically opened by the circulating nurseor other OR personnel responsible for setting up the OR for eachprocedure, such as near the OR back table. The RFID reader is preferablyconfigured so as to only sense RFID tags that are inside the enclosureand not to sense RFID tags outside the enclosure.

Some preferred embodiments include a portal containing multiple RFIDantennas connected to an RFID reader for reading RFID tags on medialitems that are passed through the portal. The RFID reader connected tothe portal antennas is preferably configured so as to only sense RFIDtags that are inside the portal and not to sense RFID tags outside theportal. Preferably, the portal is also conveniently located near thelocation where the sterile medical supplies are typically opened by thecirculating nurse or other personnel responsible for setting up the roomfor each procedure. The portal may also be located in areas wheresupplies are stored outside the procedure room and at other transitionlocations in the medical facility.

Once the packaging of a medical supply is opened, that item isconsidered “consumed” because the packaging has been compromised and itcannot be re-stocked. In preferred embodiments, as the packaging ofmedical supply items having RFID tags are opened, the packaging isdropped into the shielded enclosure and the reader reads the RFID tagson that packaging. The RFID reader is connected to a data collectioninterface, such as an ORIS computer terminal, a tablet computer or smartphone, and the consumption information for each item is logged.

This system provides an accurate way to track supply utilization thatdoes not require additional data input steps from the OR personnel.Simply throwing the discarded packaging into a waste container, which isnormal procedure, allows for the RFID tagged supplies to be registeredas consumed.

In a further preferred embodiment, a stock bin is provided. Prior toperformance of a medical procedure, all RFID-tagged medical supply itemsthat were pulled from the supply room or supply cabinet are placed inthe stock bin, the stock bin is moved through the portal or is placedinside the shielded enclosure, and the RFID reader reads the data fromthe RFID tags on the packaging. In this manner, pre-op data regardingitems pulled for use according to a particular BOM can be captured for agiven case.

Following the conclusion of the procedure, all RFID-tagged medicalsupply items that have not been opened, which are thus eligible forre-stocking, are placed into the stock bin, the stock bin is movedthrough the portal or is placed inside the shielded enclosure, and theRFID reader reads the data from the RFID tags on the packaging. In thismanner, post-op data regarding both consumption and non-consumptionrelative to a given BOM can be captured for a given case. In someembodiments, the RFID reader is connected through a data interface intothe ORIS system or the inventory management system and the dataregarding the non-consumed items are captured. The process preferablyassociates medical items (and/or their manufacturer's lot number) andinstrument trays to specific patients in the event of a recall ornegative occurrence that is determined post-case.

Once the pre-op data and post-op data are accurately collected, the datacan be very useful in myriad ways. Since consumption data is accuratelydetermined through the sensing of packaging in the waste bin, billingfor medical items consumed in the case can be more accurately reflectedon the patient's bill, thereby allowing the hospital to more accuratelycharge for the procedure. If the stock bin option is included, thisensures that items pulled for the procedure that were detected in thepre-op scan but were not consumed during the procedure are properlyreturned to inventory. This process also digitally tracks the movementof each item through various transition locations in the medicalfacility. This makes it possible to identify excessive handling of itemsand potential exposures to infectious patients.

More sophisticated data analysis can lead to significant costimprovements, such as by trending consumption and non-consumption formultiple procedures and doctors.

In some preferred embodiments, a database is provided (also referred toherein as the UDI Serialized Tracking Database) that complements theFDA's Global Unique Device Identification Database (GUDID). As medicalitems are produced, manufacturers register the lot and preferably theserial number information for each individual item in the UDI SerializedTracking Database. More importantly, each individual item registered inthe UDI Serialized Tracking Database is assigned a unique identificationnumber encoded in an Electronic Product Code (EPC) in a Radio FrequencyIdentification (RFID) tag attached to the item. The UDI SerializedTracking Database maps the unique number to the item's UDI. As each itemis consumed during medical treatment and billed to payers, the uniqueidentification number encoded in the EPC of the device is verified andreported. This provides for detection of certain types of fraud in thedispensing of medical items by validating that necessary supplies wereactually utilized during patient care (e.g. a wound debridement requiresa scalpel, etc.).

One preferred embodiment is directed to an apparatus for recordingconsumption of medical items used during performance of a medicalprocedure in a medical facility and for detecting fraud in reporting theconsumption of the medial items. The medical items are at leastinitially enclosed in wrappers having RFID tags disposed in or on thewrappers. A unique identification number that uniquely identifies anindividual medical item is encoded in each of the RFID tags. Theapparatus preferably includes a shielded enclosure having an internalspace for receiving the wrappers of the medical items, RFID antennasdisposed within the shielded enclosure, an RFID reader that iselectrically connected to the RFID antennas, and a database in whichunique identification numbers encoded in RFID tags are cross referencedto Unique Device Identifier (UDI) numbers assigned by a governmentalagency to identify specific types of medical items used in medicalprocedures. A computer is in communication with the database. Theshielded enclosure is configured to attenuate radio frequency signalsemanated from RFID tags disposed outside the shielded enclosure tolevels that are substantially undetectable within the internal space.The RFID antennas receive radio frequency signals emanated from the RFIDtags attached to the wrappers disposed within the internal space. Theradio frequency signals contain the unique identification numbersencoded in the RFID tags. The RFID reader decodes the uniqueidentification numbers contained in the radio frequency signals emanatedfrom the RFID tags. The computer has a processor that executesinstructions for:

-   -   (a) receiving the unique identification numbers decoded by the        RFID reader,    -   (b) accessing the database to determine whether each of the        unique identification numbers decoded by the RFID reader for        each medical item is valid for the UDI number assigned to        identify the specific type of medical item,    -   (c) accessing the database to determine whether any unique        identification number decoded by the RFID reader has been logged        into the database as being associated with a medical item that        was previously consumed in medical treatment of a patient, and    -   (d) generating a fraud alert message if        -   any unique identification number decoded by the RFID reader            is not valid for the UDI number assigned to identify the            specific type of medical item, or        -   any unique identification number decoded by the RFID reader            was previously logged into the database in association with            a medical item that previously consumed in medical treatment            of a patient.

In some embodiments, the computer is disposed in the medical facility,the computer is in electrical communication with the RFID reader, andthe computer executes the instructions for accessing the database andgenerating a fraud alert message automatically upon receipt of theunique identification numbers decoded by the RFID reader.

In some embodiments, the computer is associated with a medical billpayer entity that receives a bill listing the unique identificationnumbers decoded by the RFID reader, and the computer executes theinstructions for accessing the database and generating a fraud alertmessage upon entry into the computer of the unique identificationnumbers listed in the bill.

In another aspect, embodiments are directed to a method for recordingconsumption of medical items used during performance of a medicalprocedure and for detecting fraud in reporting the consumption of themedial items. The medical items are at least initially enclosed inwrappers having RFID tags disposed in or on the wrappers. A uniqueidentification number that uniquely identifies an individual medicalitem is encoded in each of the RFID tags. A preferred embodiment of themethod includes the following steps:

-   -   (a) storing a plurality of unique identification numbers in a        database in association with Unique Device Identifier (UDI)        numbers assigned by a governmental agency to identify specific        types of medical items used in medical procedures;    -   (b) during the performance of the medical procedure, depositing        the wrappers of the medical items into an internal space of a        shielded enclosure that is configured to attenuate radio        frequency signals emanated from RFID tags disposed outside the        shielded enclosure to levels that are substantially undetectable        within the internal space;    -   (c) receiving radio frequency signals emanated from RFID tags        attached to or embedded in the wrappers disposed within the        internal space, wherein the radio frequency signals contain the        unique identification numbers encoded in the RFID tags;    -   (d) decoding the unique identification numbers contained in the        radio frequency signals emanated from the RFID tags;    -   (e) accessing the database to determine whether each of the        unique identification numbers decoded from the radio frequency        signals is valid for the UDI number assigned to identify the        specific type of medical item;    -   (f) accessing the database to determine whether any of the        unique identification numbers decoded from the radio frequency        signals was previously logged into the database as being        associated with a medical item that was previously consumed        during medical treatment of a patient, and    -   (g) generating a fraud alert message if        -   any unique identification number decoded from the radio            frequency signals is not valid for the UDI number assigned            to identify the specific type of medical item, or        -   any unique identification number decoded from the radio            frequency signals was previously logged into the database in            association with a medical item that was previously consumed            in medical treatment of a patient.

In some embodiments, steps (e), (f) and (g) are performed by a computerthat is disposed in the medical facility and is in electricalcommunication with the RFID reader. In these embodiments, steps (e), (f)and (g) are performed automatically upon completion of step (d).

In some embodiments, steps (e), (f) and (g) of the method are performedby a computer that is associated with a medical bill payer entity thatreceives a bill listing the unique identification numbers decoded by theRFID reader. In these embodiments, steps (e), (f) and (g) are performedupon entry into the computer of the unique identification numbers listedin the bill.

BRIEF DESCRIPTION OF THE DRAWINGS

Other embodiments of the invention will become apparent by reference tothe detailed description in conjunction with the figures, whereinelements are not to scale so as to more clearly show the details,wherein like reference numbers indicate like elements throughout theseveral views, and wherein:

FIG. 1 depicts a system for sensing and recording consumption of medicalitems during a medical procedure according to an embodiment of theinvention;

FIGS. 2A and 2B depict shielded enclosures according to embodiments ofthe invention;

FIG. 3 depicts a method for sensing and recording consumption of medicalitems during a medical procedure according to an embodiment of theinvention;

FIGS. 4A-4F depict a portal according to an embodiment of the invention;

FIGS. 5 and 6 depict processes for sensing and recording utilization ofmedical resources in the performance of a medical procedure in a medicalfacility according to embodiments of the invention;

FIGS. 7 and 8 depict processes for generating alerts based onutilization of medical resources in the performance of a medicalprocedure in a medical facility according to embodiments of theinvention;

FIGS. 9-11 depict a system for tracking medical items through varioustransition points in a supply and consumption chain according to anembodiment of the invention;

FIG. 12 depicts an apparatus for maintaining an inventory of medicalitems according to an embodiment of the invention;

FIG. 13 depicts a computer system associated with a supply room dooraccording to an embodiment of the invention;

FIG. 14 depicts a system for detecting fraud in the reporting of usageof medial items in the treatment of medical patients according to anembodiment of the invention; and

FIG. 15 depicts a method for detecting fraud in the reporting of usageof medial items in the treatment of medical patients according to anembodiment of the invention.

DETAILED DESCRIPTION

As the term is used herein, a “medical item” is an item, material,substance, or piece of durable medical equipment (DME) that is used orconsumed during the performance of a medical procedure or that isdispensed to a patient to treat a medical condition or provide comfortto the patient. For example, sponges, gloves and drapes are medicalitems. A surgical implant is another example of a medical item. Kneebraces, negative pressure wound therapy units, blood glucose monitors,and wheelchairs are further examples of medical items. Medical itemscomprise a subset of “medical resources.” As the term is used herein, a“medical resource” is any item, person, piece of equipment, or spaceinvolved in providing medical services for a patient. For example, agurney on which a patient lies during a surgical procedure is a medicalresource. The doctor performing the procedure, the attending nurses, andthe patient are also medical resources. An operating room is a medicalresource.

As the term is used herein, a “wrapper” encompasses all manner ofcontainers and packaging, sterile or non-sterile, in which a medicalitem is or has been enclosed. The term “wrapper” also includes a label,hang tag, or other such device that may be attached to a medical itemwithout completely enclosing the item. The term “wrapper” furtherincludes packaging for a sterile-wrapped kit of medical items, such as atray of implants and supplies for use in a surgical procedure, whereinan RFID tag is attached to the tray. Generally, anything that mayfunction to associate an RFID tag with a medical item is encompassed bythe term “wrapper.”

Each medical item has a unique item identifier encoded in amachine-readable code in an RFID tag, a QR code, a bar code, or acombination thereof attached to the medical item or its wrapper. In someembodiments, an RFID tag and a QR code are combined in a single labelapplied to the medical item or its wrapper.

In a preferred embodiment, each wrapper includes an RFID tag attachedthereto or embedded therein. Ultra-High Frequency (UHF) passive RFIDtags are preferred for this application, as they may be interrogatedfrom up to about 30 centimeters away. In preferred embodiments, eachRFID tag is encoded with a unique item identification number for theparticular medical item associated with the wrapper. An item informationdatabase 52 associates each item identification number withitem-specific information, such as the manufacturer part number, itemdescription, vendor, cost, Latex content, expiration date, and inventorylocation. Additionally or alternatively, the RFID tag may be encodedwith item-specific information as set forth in Unique DeviceIdentification (UDI) standards set by the U.S. Food and DrugAdministration (FDA).

In some embodiments, item-specific information encoded in RFID tags onmedical items may be used to generate alerts for medical personnel. Forexample, an alert may be generated if information encoded in an RFID tagindicates the presence of Latex in an item, and the patient is allergicto Latex. Also, an alert may be generated if information encoded in anRFID tag indicates that an item's useful lifetime has expired or if theitem is from a lot that has been recalled by the manufacturer.

As the term is used herein, a “portal” is any passageway, opening,aperture, window, panel, wall, doorway, hallway, pathway, or aisle in ornear which one or more RFID antennas are mounted for sensing RFID tagsthat pass through or near the portal. A portal may also be a handheldscanning device for reading RFID tags. Several portals may be used totrack the routes of travel and locations of medical resources throughouta medical facility or a medical item supplier facility.

As the term is used herein, a “scan” for RFID tags refers to operationsperformed by an RFID reader to transmit signals and receive signals fromRFID tags that are in range of the RFID reader and its associatedantenna(s).

In preferred embodiments, portals are placed at “transition locations”within a medical facility or a medical item supplier facility. Examplesof transition locations include supply rooms, supply cabinets, procedurerooms, waste containers, personnel break rooms, hallways, shipmentassembly areas, shipment loading docks, and points of entry into andexit from the medical facility or a medical item supplier facility.

As the term is used herein, a “shipment” of medical items comprisesmultiple medical items, of the same type or different types, that arepackaged together at a supplier location and shipped to a location atwhich the medical items are consumed or dispensed. Generally, eachshipment includes a packing list that lists all of the medical items inthe shipment. In preferred embodiments, each packing list has a uniqueshipment identifier that encodes shipment identification informationthat is specific to the shipment. The shipment identifier may be in theform of an RFID tag, bar code, or other encoded identifier attached to,embedded in, or printed on the packing list.

Sensing and Logging Consumption of Medical Items During MedicalProcedure

As shown in FIG. 1, a system 10 for sensing and logging consumption ofmedical items during a medical procedure includes a shielded enclosure12 having a space 16 that is preferably large enough to receive a wastebin 18. Disposed within the enclosure 12 are two RFID antennas 14 a and14 b, such as Laird 5×5 inch Mini Far Field antennas (model numberS9025PLNF) having left-hand circular polarization and operating in the902-928 MHz frequency range. One of the antennas 14 a is preferablydisposed at the top of the enclosure 12, with its field of view lookingdownward into the space 16. The other RFID antenna 14 b is preferablydisposed at the bottom of the enclosure 12, with its field of viewlooking upward into the space 16. The RFID antennas 14 a-14 b areelectrically connected, such as via a coaxial cable, to a UHF RFID tagreader 28. In a preferred embodiment, the RFID tag reader 28 is anImpinj® Speedway® model R420.

Preferred embodiments of the shielded enclosure 12 are shown in FIGS. 2Aand 2B, wherein the sidewalls are depicted as transparent. The enclosure12 is preferably made from 0.080 inch thick sheet aluminum supported by0.75×0.75 inch square aluminum tubing (0.125 thick). The outsidedimensions of the preferred embodiment are 23.5×22.0×40.75 inches.

As the term is used herein, “shielded” means that the enclosure 12 isdesigned to prevent the antennas 14 a-14 b from receiving RFID signalsfrom RFID tags located outside the enclosure 12 at a signal-to-noiseratio high enough to trigger detection of those outside RFID tags. Forpurposes of this disclosure, “shielded” does not mean that absolutelyall RF energy is blocked from entering the enclosure, as this wouldrequire unnecessary levels of shielding.

In some embodiments, an opening 24 is provided in the top of theenclosure that is large enough to receive wrappers or containers 20 fromwhich medical items have been removed. The opening 24 is preferably a6.75×13.75 inch rectangle. An aluminum cover 25 is provided over theopening 24. The cover may be slanted as shown in FIG. 2A or morebox-like as shown in FIG. 2B to prevent signals from escaping theenclosure 12. As shown in FIG. 2B, the enclosure preferably includes analuminum chute 23 around the opening 24, and an aluminum shield 27around the antenna 14 a. These structures provide further attenuation ofRFID signals originating outside the enclosure 12 to prevent thosesignals from being detected by the antennas 14 a-14 b. The waste bin 18is positioned below the opening 24 so that wrappers 20 deposited in theopening 24 fall into the bin 18. In a preferred embodiment, a hingeddoor 26 large enough to receive the waste bin 18 is provided in asidewall of the enclosure 12. The door 26 is preferably 29.5×39.25 inch,and includes a handle/latch for securing the door in a closed position.The enclosure 12 is considered to be shielded when the door 26 isclosed.

In a preferred embodiment, the system 10 includes a portal 48 having anopening 49 at least large enough to receive the waste bin 18. The portal48 is preferably equipped with four RFID antennas 50 a-50 d havingfields of view looking inward into the portal opening 49. The RFIDantennas 50 a-50 d are electrically connected, such as via coaxialcables, to a UHF RFID tag reader 46. In a preferred embodiment, the RFIDtag reader 46 is an Impinj® Speedway® model R220. In some embodiments,the tag reader 46 and the tag reader 28 comprise a single tag reader.

The waste bin 18, also referred to herein as a waste tote, is preferablya plastic container having an open top for receiving wrappers 20. Insome embodiments, an RFID tag 22 encoded with a unique binidentification number is attached to the waste bin 18. The database 52associates the bin identification number with a particular procedureroom to which the waste bin 18 is assigned. Alternatively, the RFID tag22 may be encoded with information indicating the procedure room towhich the bin 18 is assigned.

The RFID tag readers 28 and 46 are electrically connected via a localarea network (LAN) 42 to a medical item inventory computer 31, which maybe a server computer, desktop computer, laptop computer, tablet computeror other mobile computing device. Alternatively, the electricalconnection between the RFID tag readers 28 and 46 and the computer 31 isvia a Universal Serial Bus (USB) interface. The computer 31 includesmemory for storing and a processor for executing instructions of amedical item inventory module 40. In preferred embodiments, the medicalitem inventory module 40 compiles pre-op and post-op lists of items,compares the lists to detect discrepancies, generates alert messagesupon detection of discrepancies, and updates inventory records based onactual item usage.

In a preferred embodiment, an Operating Room Information System (ORIS)computer 30 is in communication with the medical item inventory computer31 via a communication network, such as the LAN 42. The ORIS computer 30is also in communication with a hospital computer system 32 via acommunication network, such as the LAN 42. In preferred embodiments, thehospital computer system 32 manages medical item inventories, operatingroom scheduling, patient records, insurance reimbursement/paymentfunctions, and admission/discharge/transfer (ADT) records. The hospitalcomputer system 32 may also include or be connected to an electronicdata interchange server, such as a J.D. Edwards/Oracle server, thatimplements electronic commerce transactions between the hospital andmedical item suppliers.

In some embodiments, the medical item inventory module 40 is a softwareapplication running on the computer 31. In alternative embodiments, themedical item inventory module 40 is executed by a remote computer(outside the OR). For example, the medical item inventory module 40 maybe implemented as “software-as-a-service” provided via the Internet by amedical item inventory service provider.

With continued reference to FIG. 1, a preferred embodiment of the system10 includes a stock bin 34, which may also be referred to herein as atransport bin or stock tote. As described in more detail below, thestock bin 34 is used to transfer medical items 38 to be used during amedical procedure from a stock room to the procedure room, and totransfer unused medical items 38 from the procedure room back to thestock room. In some embodiments, an RFID tag 36 is attached to the stockbin 34 that is encoded with a unique bin identification number. In someembodiments, the database 52 associates the bin identification numberwith a particular procedure room or stock room to which the stock bin 34is assigned. Alternatively, the RFID tag 36 may be encoded withinformation indicating the procedure room or stock room to which thestock bin 34 is assigned.

FIG. 3 depicts a preferred embodiment of a process 100 for sensing andrecording consumption of medical items during a medical procedure usingthe system depicted in FIG. 1. To begin the process, hospital personnelpick medical items from inventory stock to be used during the medicalprocedure (step 102 in FIG. 3). For example, the needed items may belisted on a Bill of Materials (BOM) for the particular type of procedureto be performed. In some cases, the BOM also reflects the individualpreferences of particular doctors. These types of BOM's may also bereferred to as Doctor Preference Cards. The picked items are placed inthe stock bin 34 to be transferred to the OR.

In one embodiment, the stock bin 34 containing the picked items 38 isplaced in or passed through the portal 48 outside the procedure room(step 104) and the RFID reader 46 reads the RFID tags on the wrappers ofthe items 38 in the stock bin 34 (step 106). In some embodiments,activation of the reader 28 is triggered manually by a person in theprocedure room using an interface device (mouse, touchpad or keyboard)of the computer 31.

The item identification numbers read from the RFID tags in the portal 48are transferred to the medical item inventory computer 31 where themedical item inventory module 40 compiles a pre-op list of the items 38in the stock bin 34 (step 108). In a preferred embodiment, the date/timeof the compilation of the list is recorded in the medical item inventorycomputer 31, along with the identification number of the stock bin 34.Other information may be associated with the pre-op list, such asprocedure room number, doctor name, patient name, patient age, patientweight, patient allergies, type of medical procedure, and case number.Once the pre-op list is compiled, the RFID reader 28 may be deactivated(step 109) and the stock bin 34 removed from the portal 48 (step 110).

Steps 104-110 of FIG. 3 are optional and are not implemented in allembodiments of process 100. If these steps are not performed, the BOMfor the medical procedure may serve the purpose of the pre-op item list.

The items 38 are preferably removed from the bin 34 and arranged on atable in the procedure room according to the doctor's or attendingnurse's preference. As the items 38 are used/consumed during theprocedure (step 112), wrappers 20 removed from the items 38 are droppedthrough the opening 24 in the enclosure 12 where they are received intothe waste bin 18 (step 114). When the wrappers 20 enter the enclosure12, the RFID tags on the wrappers 20 are detected and read by the reader28 (step 116). It will be appreciated that a waste bin 18 is notabsolutely necessary for this process. However, the use of a waste bin18 makes collection and removal of the wrappers 20 easier.

The item identification numbers read from the RFID tags in the enclosure12 are transferred to the medical item inventory computer 31 where themedical item inventory module 40 compiles a post-op used-item list ofthe wrappers 20 (step 118). In a preferred embodiment, the date/timethat each wrapper 20 was first detected is recorded in the list. Also,the identification number of the waste bin 18 (if any) and otherinformation may be associated with the post-op used-item list, such asprocedure room number, doctor name, patient name, type of medicalprocedure, and case number. Once the post-op used-item list is compiled,the RFID reader 28 is deactivated (step 119) so that it will not readany other tags when the door 26 is opened to remove the wrappers 20(step 120). Deactivation of the reader 28 may be triggered by openingthe door 26 of the enclosure 12.

In an alternative embodiment, the waste bin 18 remains outside theshielded enclosure 12 during the procedure. As the items 38 areused/consumed during the procedure (step 112), wrappers 20 removed fromthe items 38 are deposited in the waste bin 18. After completion of theprocedure, the waste bin 18 containing the wrappers 20 is placed throughthe portal 48 (step 114), and the reader 28 reads the RFID tags of thewrappers 20 (step 116). The post-op used-item list is compiled asdescribed in the previous embodiment (step 118).

In some embodiments, after completion of the medical procedure, allunused items 38 are placed back into the stock bin 34, and the stock bin34 is passed through the portal 48 (step 122). The reader 46 reads theRFID tags of the unused items 38 (step 124), and a post-op unused-itemlist is compiled (step 126). The identification number of the stock bin34 and other information may be associated with the post-op unused-itemlist, such as procedure room number, doctor name, patient name, type ofmedical procedure, and case number.

Steps 122-126 of FIG. 3 are optional and are not implemented in allembodiments of process 100. If these steps are not performed, thepost-op unused-item list may be generated by comparing the BOM to thepost-op used item list.

Various embodiments of the invention use the pre-op and post-op itemlists to implement various advantageous inventory and billing functions.For example, the medical item inventory module 40 may compare the itemslisted in the pre-op list to the items listed in the post-op used-itemlist and the post-op unused-item list (step 128). If an item in thepre-op list does not appear on either of the post-op lists (step 130),this means the item was brought into the procedure room but neither theitem nor its wrapper ended up in the stock bin or the waste bin afterthe procedure. In this case, an alert is generated that causes a messageto appear on a display screen of the ORIS computer 30 or the medicalitem inventory computer 31 (step 132). The alert should prompt theprocedure room personnel to investigate three possibilities that mayhave caused the discrepancy: (1) the item is unused and still in theprocedure room but was inadvertently not placed back into the stock binbefore the post-op unused-item list was compiled, (2) the item was usedand its wrapper is still in the procedure room but the wrapper wasinadvertently not placed in the waste bin before the post-op used-itemlist was compiled, or (3) the item and/or its empty wrapper was removedfrom the procedure room prior to compilation of either of the post-oplists. In any event, the missing item(s) or wrapper(s) should be locatedand the pre-op and post-op lists reconciled (step 134).

If the comparison of the pre-op and post-op item lists indicates that anitem that appears on either of the post-op lists is not on the pre-oplist (step 136), this means that the item or its wrapper was present inthe procedure room when the post-op lists were compiled, but it was (1)not brought into the procedure room in the stock bin with the otheritems, or (2) brought into the procedure room in the stock bin but wasremoved from the stock bin prior to compilation of the pre-op list. Inthis case, an alert is generated which causes a message to appear on adisplay screen of the computer 31 (step 138). The alert should promptthe procedure room personnel to investigate what may have caused thediscrepancy and reconcile the pre-op and post-op lists (step 140).

In a preferred embodiment, once the post-op lists are complete andreconciled, the computer 31, the ORIS computer 30, or the hospitalcomputer system 32 uses the lists to update the database 52 based onactual item usage (step 142). The hospital computer system 32 or theORIS computer 30 also may use the post-op used-item list to accuratelybill the patient (or insurance company) for the items used during theprocedure (step 146). The stock bin 34 may be returned to theappropriate inventory stock room where the unused items 38 may bereturned to inventory (step 144).

In preferred embodiments, the hospital computer system 32 or the MedicalItem Inventory Application 40 analyzes the post-op unused-item listsgenerated during multiple procedures of the same type and for the samedoctor to determine trends in the lack of usage of certain medical itemsthat are listed on BOM's (step 146). This trend data may be used torevise the BOM's for certain procedures/doctors. For example, if thetrend data indicates that in 90% of hip replacement surgeries performedby Dr. Jones only three sponges of a particular type are used out of thefive called for on the BOM, the BOM may be revised to call for onlythree sponges. Revisions of this sort would reduce the effort/costassociated with returning unused items to the stock room, and woulddecrease traffic in and out of the procedure room during a procedurewhich would decrease the chances of a site infection. Trend data mayalso be used to determine the optimal locations to store medicalsupplies and the optimal quantities to store.

Tracking Utilization of Medical Resources in Medical Facility

Various embodiments described herein provide systems for sensing RFIDtags attached to various medical resources at various transitionlocations throughout a medical facility, for tracking routes of movementof the medical resources based on the sensing of the RFID tags, fordetecting relationships between medical resources based on sensing theirRFID tags at the same transition locations during overlapping timeperiods, for analyzing utilization of the medical resources, and fordeveloping utilization profiles. For example, FIG. 5 depicts anembodiment of a process 400 for analyzing the utilization of twodifferent medical resources based on sensing (or not sensing) their RFIDtags at two different transition locations within a medical facility.The process 400 involves attaching RFID tags to medical resources (step402), disposing RFID-sensing portals at various transition locationswithin the medical facility (step 404), reading medical resourceinformation from the RFID tags using the portals (step 406 and 412), anddecoding the medical resource information to identify the medicalresources (step 408 and 414) and determine various characteristics ofthe resources as described in more detail below.

For example, with continued reference to FIG. 5, a first medicalresource is detected at a first transition location at a time T1 (step410) and at a second transition location at a time T2 (step 416). Basedon these detections, the system determines that the first medicalresource travelled from the first transition location to the secondtransition location between times T1 and T2 (step 418). Based on thisroute of travel and the times of detection, the system creates autilization profile for the first medical resource (step 420).

A second medical resource is detected at the first transition locationat a time T3 (step 422), which may be less than, greater than, or equalto time T1. The second medical resource is again detected at the firsttransition location at a time T4 (step 426), which is occurs after timeT3 (T4>T3). There is no detection of the second medical resource at thesecond transition location between times T3 and T4 (step 424). Based onthese detections, the system determines that the second medical resourcetravelled from the first transition location back to the firsttransition location between times T3 and T4, and did not travel to thesecond transition location (step 428). Based on this route of travel andthe times of detection, the system creates a utilization profile for thesecond medical resource (step 430).

In the example of FIG. 5, the first transition location may be anentrance/exit door of a medical procedure room PR1 within a medicalfacility, the second transition location may be a waste container WC1within the medical procedure room PR1, the first medical resource may bea first medical item that was picked to be used during a medicalprocedure MP1 in the procedure room PR1, and the second medical resourcemay be a second medical item that was picked to be used during the samemedical procedure MP1 in the procedure room PR1. Based on the detectionsdescribed above, the system determines that the first medical itementered the medical procedure room PR1 (first transition location) attime T1, and it or its wrapper was deposited in the waste container WC1(second transition location) at time T2. Based on this route of travel,the system creates a utilization profile indicating that the firstmedical item was used or consumed during the medical procedure MP1. Alsobased on the detections described above, the system determines that thesecond medical item entered the medical procedure room PR1 (firsttransition location) at time T3, exited the medical procedure room PR1(first transition location) at time T4, and was not deposited in thewaste container WC1 (second transition location). Based on this route oftravel, the system creates a utilization profile indicating that thesecond medical item was brought into the medical procedure room PR1, butwas not used during the medical procedure MP1.

FIG. 6 depicts an embodiment of a process 440 for analyzing theutilization of three different medical resources based on their RFIDtags being sensed (or not sensed) at two different transition locationswithin a medical facility. The process 440 involves reading medicalresource information from RFID tags attached to three medicalresources—a first medical item, a doctor, and a patient—using portals atthe entrance/exit of a procedure room PR1 and on a waste container WC1(step 442 and 448), and decoding the medical resource information toidentify the medical resources (step 444 and 450) and determine variouscharacteristics of the resources. As in the previous example, the systemdetermines that the first medical item entered the medical procedureroom PR1 at time T1, and it or its wrapper was deposited in the wastecontainer WC1 at time T2 (step 454). Based on this route of travel, thesystem creates a utilization profile indicating that the first medicalitem was used during the medical procedure MP1 (step 456).

With continued reference to FIG. 6, the system detects the doctor D1entering the medical procedure room PR1 at time T3 which may be lessthan, greater than, or equal to time T1 (step 458). The doctor D1 isdetected leaving the medical procedure room PR1 at time T4 which isgreater than T1 and T3 (step 460). Based on this route of travel, thesystem creates a utilization profile indicating that the doctor D1 wasinvolved in a medical procedure MP1 in the procedure room PR1 betweentimes T3 and T4 (step 464). In preferred embodiments, the utilizationprofile for the doctor D1 indicates that the first medical item wasconsumed or used during a medical procedure MP1 performed by the doctorD1. In some embodiments, the utilization profile for the first medicalitem also indicates that the first medical item was consumed or usedduring a medical procedure MP1 performed by the particular doctor D1.

With continued reference to FIG. 6, the system detects the patient P1entering the medical procedure room PR1 at time T5 which may be lessthan, greater than, or equal to time T1 (step 466). The patient P1 isdetected leaving the medical procedure room PR1 at time T6 that isgreater than T1 and T5 (step 468). Based on this route of travel, thesystem creates a utilization profile indicating that the patient P1 wasinvolved in a medical procedure MP1 in the procedure room PR1 betweentimes T5 and T6 (step 470). In preferred embodiments, the utilizationprofile for the patient P1 also indicates that the first medical itemwas consumed or used during the medical procedure MP1 performed on thepatient P1 by the particular doctor D1. In some embodiments, theutilization profile for the first medical item also indicates that thefirst medical item was consumed or used during the medical procedure MP1performed on the particular patient P1. In some embodiments, theutilization profile for the doctor D1 also indicates that the firstmedical item was consumed or used during the medical procedure MP1performed on the particular patient P1.

Generating Alerts Based on Utilization of Medical Resources in MedicalFacility

FIG. 7 depicts a preferred embodiment of a process 480 for generating analert based on utilization of medical resources in the performance of amedical procedure in a medical facility. This process 480 analyzes theutilization of two different medical resources based on sensing theirRFID tags at the same transition location within the medical facility.The process 480 involves reading medical resource information from RFIDtags attached to the two medical resources—a first medical item and apatient P1—using portals at the entrance/exit of a procedure room PR1(step 482), and decoding the medical resource information to identifythe medical resources (step 484) and to determine variouscharacteristics of the resources. For example, the medical resourceinformation decoded at step 484 may indicate whether the first medicalitem contains a potential allergenic, such as Latex, and whether thepatient P1 is allergic to any drugs or substances, such as Latex. Usingthe decoded information, the system detects that the first medical itementered the medical procedure room PR1 (step 486) at a certain time andthat the patient P1 entered the medical procedure room PR1 at a certaintime (step 492). If the first medical item contains a substance to whichthe patient P1 is allergic, and the first medical item and the patientP1 are in the procedure room PR1 simultaneously (steps 488, 494 and496), the system generates an alert informing personnel in the procedureroom PR1 of the potential for a harmful allergic reaction (step 498).This alert may be audible (siren) and visible (strobe lights) in theprocedure room, and it may be sent via electronic messaging to otherpersonnel within the medical facility to give notice of the situation.In preferred embodiments, the occurrence of such an event is alsoreflected in the utilization profile of the patient P1.

In some embodiments, the system generates a potential allergic reactionalert if an RFID reader portal at the doorway of a supply room detects amedical item leaving the supply room that was picked for use during amedical procedure involving a patient that is allergic to a substance inthe medical item. This detection could also be made by any RFID readerportal at any transition location between the supply room and themedical procedure room.

FIG. 8 depicts a preferred embodiment of another process 500 forgenerating an alert based on utilization of medical resources in theperformance of a medical procedure in a medical facility. This process500 analyzes the utilization of two different medical resources based onsensing their RFID tags at the same transition location within themedical facility. The process 500 involves reading medical resourceinformation from RFID tags attached to the two medical resources—a firstmedical item and a patient P1—using portals at the entrance/exit of aprocedure room PR1 (step 502), and decoding the medical resourceinformation to identify the medical resources (step 504) and todetermine various characteristics of the resources. For example, themedical resource information decoded at step 504 may indicate that thepatient P1 is infected with a highly infectious contagion, such asMethicillin-resistant Staphylococcus aureus (MRSA). Using the decodedinformation, the system detects that the first medical item entered themedical procedure room PR1 (step 506) at time T1 and that the patient P1entered the medical procedure room PR1 at a certain time (step 514). Thesystem later detects that the first medical item has exited the medicalprocedure room PR1 (step 508) at time T2. If the first medical item wasnot deposited in a hazardous waste container prior to leaving theprocedure room PR1, and the first medical item and the patient P1 werein the procedure room PR1 simultaneously, and the patient P1 is infectedwith a contagion such as MRSA (steps 510, 516, 518), the systemgenerates an alert informing personnel in the procedure room PR1 of apotential for spread of a highly infectious contagion due to possiblecontact with the first medical item (step 520). This alert may beaudible (siren) and visible (strobe lights) in the procedure room, andit may be sent via electronic messaging to other personnel within themedical facility to give notice of the situation. In preferredembodiments, the occurrence of such an event is also reflected in theutilization profile of the first medical item. In some situations, thedetermination that the patient is infected (step 516) may be made afterthe procedure is complete and the patient has left the procedure room.In such situations, the system will generate the alert (step 520) afterinformation indicating the patient's infection is entered into thepatient's record (the medical resource information for the patient.)

Tracking Custody of Medical Items in Supply and Consumption Chain

FIGS. 9-11 depict a system for tracking medical items through varioustransition points in a supply and consumption chain. As shown in FIG. 9,each shipment 54 of medical items 38 includes a packing list 56 that hasa unique shipment identifier 58 encoded in an RFID tag and/or a bar codeattached to the packing list. Upon packing of medical items 38 at asupplier facility for shipment (first transition point), a unique itemidentifier 39 encoded in an RFID tag and/or a bar code attached to eachpacked medical item 38 and the unique shipment identifier 58 of theaccompanying packing list 56 are read by one or more reading devices 59and are cross-referenced in a supplier inventory database 60. Inpreferred embodiments, the reading devices 59 may include one or moreRFID tag readers and their associated antennas and one or more bar codereaders. The one or more reading devices 59 may also read the uniquepersonnel identifier 55 of the person responsible for the shipment ofmedical items at the supplier facility, which identifier may be encodedin the person's ID badge 57. In a preferred embodiment, the uniqueshipment identifier 58 is also cross-referenced in the supplierinventory database 60 with the unique personnel identifier 55. As theterm is used herein, a “supplier facility” is any location at which themedical items are disposed prior to shipment to the medical facility,such as a manufacturer facility or a distributor facility.

Upon receipt of the shipment 54 of medical items at the medical facility(second transition point), the unique shipment identifier 58 of thepacking list 56 is read and decoded by one or more reading devices 62,and the unique shipment identifier is stored in the medical facilityinventory database 52 in association with a unique personnel identifier65 of the person responsible for receiving the shipment of medical itemsat the medical facility. In preferred embodiments, the one or morereading devices 62 may include one or more RFID tag readers and theirassociated antennas and one or more bar code readers. The one or morereading devices 62 may also read the unique personnel identifier 65 ofthe person responsible for receiving the shipment of medical items atthe medical facility, which identifier may be encoded in the person's IDbadge 63.

Upon unpacking a received shipment 54 of medical items and placementinto storage bins 70 in a supply room 68 at the medical facility (thirdtransition point), the unique shipment identifier 58 and the unique itemidentifier 39 on each medical item 38 is read and decoded by one or morereading devices 66, and the unique item identifier 39 of each medicalitem 38 is stored in association with a unique supply room identifier inthe inventory database 52 for the medical facility. In preferredembodiments, the one or more reading devices 66 may include one or moreRFID tag readers and their associated antennas and one or more bar codereaders. In preferred embodiments, the inventory database 52 alsocross-references the unique item identifiers 39 with a unique personnelidentifier 69 of the person responsible for placement of the medicalitems into inventory at the medical facility, which identifier may beencoded in the person's ID badge 67.

As shown in FIG. 10, upon pulling medical items 38 from the supply roomstorage bins 70 to be used in a medical procedure, examination or test,or to be otherwise dispensed to a patient (fourth transition point), theunique item identifier 39 on each medical item 38 is read and decoded bya portal reading device 41 in the supply room, and the unique itemidentifier of each medical item is stored in the inventory database 52in association with a unique bill of material (BOM) identifier 73 of theBOM 74 for the procedure/exam/test. In a preferred embodiment, theunique item identifiers 39 and BOM identifier 73 is cross-referenced inthe database 52 with a unique personnel identifier 75 of the personremoving the medical items from the supply room, which identifier may beencoded in the person's ID badge 71. At this point, the medical itemsmay be in a transport bin 34.

Upon delivery of the medical items 38 to a procedure room, examinationroom, or test room in the medical facility (fifth transition point), theunique item identifier 39 on each medical item is read and decoded by aportal reading device 48 in or at the entrance to theprocedure/exam/test room, and the unique item identifier of each medicalitem is stored in the inventory database 52 in association with a uniqueprocedure/exam/test room identifier and a unique personnel identifier 49of a person accepting delivery in the procedure/exam/test room. Theunique personnel identifier 49 may be encoded in the person's ID badge47.

As shown in FIG. 11, upon dispensing the medical items 38 to a patientor otherwise consuming the medical items during a procedure or testperformed on the patient in the procedure/exam/test room (sixthtransition point), the unique item identifier 39 on the packaging 20 ofeach used medical item is read and decoded by a reading device 28associated with the waste bin 18 in the supply room, and the unique itemidentifier of each medical item is stored in the inventory database 52in association with a unique patient identifier.

The medical items 38 that are not used or consumed during the medicalprocedure are preferably placed back into the transport bin 34, thetransport bin 34 is passed through the portal 48, and the reader 46reads the RFID tags of the unused items 38. In a preferred embodiment,the item identification information encoded in those RFID tags iscross-referenced in the database 52 with a unique personnel identifierof the person removing the unused medical items from the medicalprocedure room and transporting the items to the supply room forrestocking, which identifier may be encoded in the person's ID badge.

At each transition point, a prompt may be automatically generated toremind the responsible personnel to scan the unique item identifier 39on each medical item 38 so that the information will be entered into theinventory database 52, or to remind the responsible personnel to takeother action as may be necessary based on the location and status of themedical items 38. These prompts may be visual or audible.

In this preferred embodiment, the inventory database 52 maintains achain of custody for each item 38 through each transition point (and foreach shipment 54 of items between the first and second transitionpoints) and keeps records of the personnel responsible for each item orshipment at each location at any particular time.

At some transition points, individual medical item information may notbe specifically recorded, although bulk information associated with thepacking list 56 will be recorded. When the medical items are dispensedto the subsequent transition point, the unique item identifiers 39 mayrecovered and the unique item identifier information can beautomatically associated with the dispensing activity where unique itemidentifier information was previously not recorded.

Although a particular sequence of transition points is described,transition points could consist of any handling point along the supplychain for a medical item from manufacturer to patient.

In further embodiments, each transition point is defined by the type oflocation. Each type of location may have a set of characteristicsassociated with that location type that trigger certain action promptswhen the medical items are associated with that particular location typein the database 52. For example, when the shipment 54 of medical itemsis received at a supply room 68, such as by scanning the identificationinformation on a packing list 56, the supply room identificationequipment may prompt the inventory management personnel to place theproducts in the appropriate product storage location, initiate an RFIDscan of the room to identify the medical items present in the room andsubsequently present information to the inventory management personnelto determine if the room inventory, as updated, reconciles with thepacking list.

In another example, when the RFID reader 48 in a procedure/examinationroom detects in the room a medical item that is considered to be DurableMedical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS, alsocollectively referred to herein simply as “DME”), and it also detects apatient identification number encoded in an RFID tag associated with aparticular patient in the room, the procedure room computer 30 maygenerate action prompts based on association of the DME item with thepatent. For example, the procedure room computer 30 may prompt thetreating personnel to disclose to the patient certain informationrelated to the proper use of the DME item, to input information toverify the delivery of the DME item to the patient, or to obtain thepatient's signature to acknowledge receipt of the DME item. In asituation in which an old or used DME item is detected in the room, andthe patient is supposed to receive a new item, the system may generate anotification to treating personnel that the old/used item should go backto hospital stock and a new item should be dispensed to patient.

In some embodiments, the exits of the hospital or other medical facilityare transition points at which networked RFID tag readers arepositioned. When a just-dispensed DME item is detected at any of theseexit transition points, the medical item inventory computer 31 triggersa billing change event to cause the billing for the DME item to changefrom Medicare Part A, in which the medical facility pays for rental, toMedicare Part B, in which the patient or the patient's insurance companyis billed for the item. This exit event may also cause the medical iteminventory computer 31 to update the chain of custody for the DME item toindicate a transfer of possession from the medical facility to thepatient. Such an exit event may also trigger the sending ofnotifications to the patient and medical personnel regarding follow-upcare for patient using the DME item, such as notifications recommendinga Part B healthcare provider and prompting the scheduling of follow-upappointments.

Medical Item Supply Room

FIG. 12 depicts a functional block diagram of features of a medical itemsupply room 68 according to a preferred embodiment. Within the supplyroom 68 are one or more storage bins 70 in which medical items 38 arestored until they are needed for treatment of a patient. As the term isused herein, a “storage bin” is any storage structure in or on whichmedical items may be stored, including but not limited to a container,shelf, drawer, hanger, or cabinet. One or more RFID antennas 72 aredirected toward the storage bins 70 to detect RFID tags on medical items38 stored therein. The antennas 72 are electrically connected to one ormore RFID tag readers 66 that are in communication with the medicalfacility network 42. In some embodiments, a supply room computer 64 isprovided to allow personnel in the supply room 68 to access medical iteminventory information over the network 64.

In some embodiments, the supply room 68 has RF shielding 76 in thewalls, floor and ceiling to prevent detection of RFID tags that areoutside the supply room. RFID shielding 76 may also be provided ingaskets around the edges of the door frame and in a door sweep on thebottom of the door.

In some embodiments, a computer 78 is built into the door 74 of themedical item supply room 68. As shown in FIG. 13, this computer 78preferably includes a processor 80, a touch screen display 82, keypad84, biometric sensor 86 such as a fingerprint reader or retinal scanner,and a code reader 90, such as an RFID reader, barcode reader or magneticstripe reader, for reading identification information of personnelseeking access to the supply room and decoding the unique personnelidentifiers encoded personnel ID badges. In a preferred embodiment, theprocessor 80 interfaces with one or more sensors 85 that sense whetherthe door 74 is in an open state or a closed state and/or whether thedoor is locked or unlocked.

The computer 78 may also interface with a door lock controller 88 toallow or deny access to the room based on the identity of the personseeking access and based on ongoing activities in the room. For example,if another person is in the room entering items into inventory, thecomputer may be programmed to not allow access so as not allow outsideRFID signals into the room and interfere with the ongoing inventoryactivity. The computer 78 may also be programmed to keep the door lockedwhile an RFID scan is taking place, whether or not anyone is in theroom. The computer 78 may also be programmed to deactivate the RFIDreader 66 inside the room when the door is open so that no RFID tags onitems outside the room will be detected.

In some embodiments, the supply room computer 64 or the computer 78controls the RFID tag reader(s) 66 to perform an RFID antennacalibration procedure. This procedure may involve placing a known numberof RFID-tagged items in various different storage bins 70 in the supplyroom 68 with the RFID tag reader 66 initially deactivated. The computer64 then activates the RFID tag reader 66 at a first relatively lowtransmitter power level and the number of tags detected is noted. If notall the tags present in the room were detected, the transmitter powerlevel is increased by a small amount to a second power level that isgreater than the first power level and the number of tags detected isnoted. This procedure is repeated until all tags are detected, and thelowest transmitter power level at which all tags were detected is storedas the optimum operational level. This general procedure could also beperformed by starting at a relatively high transmitter power level atwhich all tags are detected and then stepping down in power until notall of the tags are detected.

UDI Fraud Detection.

FIG. 14 depicts a preferred embodiment of a system 200 for detectingfraud in the reporting of usage of medical items in the treatment ofmedical patients, and FIG. 15 depicts a process performed by the systemof FIG. 14 to detect and report such fraud. The system 200 includes asupplier inventory computer 202 in communication with a supplier RFIDtag encoder 204, both of which are disposed at a supplier facility. Thesystem 200 also includes a distributor inventory computer 210 incommunication with a distributor RFID tag reader 208, both of which aredisposed at a distributor facility. A medical care facility inventorycomputer 214 is in communication with a supply room RFID tag reader 212and a procedure room RFID tag reader 216, all of which are disposed at amedical care facility. As shown in FIG. 1, one embodiment of theprocedure room RFID tag reader 216 is the tag reader 28 connected to theantennas 14 a-14 b in the shielded enclosure 12 disposed in a medicalprocedure room. Another embodiment of the procedure room RFID tag reader216 is the tag reader 46 connected to the antennas 50 a-50 d in theportal 48. The supplier inventory computer 202 and the medical carefacility inventory computer 214 are in communication with a UDISerialized Tracking Database 218. In a preferred embodiment, thedatabase 218 is maintained at the facility of a third party UDI frauddetection service provider.

The medical item supplier assigns each individual instance of a medicalitem a unique identification number (e.g. GS1, SGTIN, EPC, etc.) that isencoded in an RFID tag 206 attached to the device or its packaging. Forexample, if twenty items having the same Device Identifier (DI) aremanufactured in the same lot/batch, each of the twenty items has adifferent unique identification number encoded in an attached RFID tag.The unique identification number is preferably encoded in the RFID tag206 for each item at the time of manufacture using the tag encoder 204(step 302 in FIG. 15). Preferably, RFID chip security is utilized tolock the RFID tag 206 after programming to prevent the uniqueidentification number on the tag from being modified. As an option insome embodiments, the unique identification number is also visuallydisplayed on the packaging and encoded in a barcode on the packaging.

The unique identification number encoded in the RFID tag 206 is assignedto the corresponding UDI (i.e. DI and PI) for the particular medicalitem and is registered with the UDI fraud detection service provider forstorage in the UDI Serialized Tracking Database 218 (step 304).Preferably, this registration process is performed at the time ofmanufacture.

The tagged medical items are shipped from the supplier to thedistributor (step 305), and the tags on incoming items are read at thedistributor facility using the distributor RFID tag reader 208 (step306). The distributor computer 210 then communicates with the UDISerialized Tracking Database 218 to update the status of the taggedmedical items (step 308).

After the medical items are shipped from the distributor to the medicalcare facility (step 310), the tags on the incoming items are read usingthe supply room RFID tag reader 212 (step 312). The care facilitycomputer 214 then communicates with the UDI Serialized Tracking Database218 to update the status of the tagged medical items (step 314).

When a medical item is used during a procedure to treat a patient (step316), the unique identification number of the item is logged by scanningthe RFID tag attached to or embedded in the item or its wrapper usingthe RFID tag reader 216 in the procedure room (step 318). In preferredembodiments described herein, the RFID tags on item wrappers areautomatically read when the wrappers are dropped into the shieldedenclosure 12 (FIG. 1). In alternative embodiments, the RFID tags on orembedded in item wrappers are automatically read when the wrappers passthrough the portal 48. The care facility computer 214 then communicateswith the UDI Serialized Tracking Database 218 to update the status ofthe tagged medical items (step 320). Using this information, the UDIfraud detection service provider can track the status (i.e., used inpatient care or not yet used in patient care) of each individualinstance of each medical item.

At some point after the procedure, the medical care provider submits theunique identification numbers encoded in the RFID tags 206 of used itemsin a bill to a payer (step 322). The bill payer, or any other entitywishing to validate that the devices listed on bills were actually usedduring patient care, may access the UDI Serialized Tracking Database 218such as via a dedicated website to perform an anti-fraud check (step324). In a preferred embodiment, such a check involves two steps: (a)checking that the submitted unique identification number is valid forthe UDI (e.g. that the unique number submitted for a scalpel is a validunique number for a scalpel)(step 326), and (b) validating that the sameunique number has not been submitted more than once based on treatmentof two different patients (step 328). If the unique identificationnumber of a used medical item is not valid for the device type indicatedby the UDI (step 326), a fraud alert message is generated (step 330). Afraud alert message is also generated if the unique identificationnumber has been submitted previously in association with a prior patientcare event (step 328). Fraud alert messages may be provided in the formof emails, text messages, notifications on a UDI fraud check websitescreen, or by other forms of electronic messaging.

In some embodiments, an automatic fraud check is triggered based on thereading of an RFID-tagged wrapper dropped into the shielded enclosure(step 318) and the logging of the decoded unique identification numberinto the database 218. This automatic fraud check (indicated by thedashed line in FIG. 15.) preferably occurs independently of thesubmission of a bill to a payer. Thus, the automatic fraud check mayfind potential problems even before a bill is submitted to a payer. Forexample, during the automatic fraud check, it may be determined at step328 that the unique identification number for the used item matches theunique identification number of an item that was logged previously intothe database 218 as being used in a procedure. Since it is not possiblefor the same consumable item to have been used twice, the first “use” ofthe item must have been logged fraudulently in order to inflate a bill.This information can be used to investigate the first logged “use” toeither track down the perpetrator of the fraud or to determine whether amistake was made due to negligence or carelessness rather than anintentionally fraudulent act.

The foregoing description of preferred embodiments for this inventionhave been presented for purposes of illustration and description. Theyare not intended to be exhaustive or to limit the invention to theprecise form disclosed. Obvious modifications or variations are possiblein light of the above teachings. The embodiments are chosen anddescribed in an effort to provide the best illustrations of theprinciples of the invention and its practical application, and tothereby enable one of ordinary skill in the art to utilize the inventionin various embodiments and with various modifications as are suited tothe particular use contemplated. All such modifications and variationsare within the scope of the invention as determined by the appendedclaims when interpreted in accordance with the breadth to which they arefairly, legally, and equitably entitled.

What is claimed is:
 1. An apparatus for recording consumption of medicalitems used during performance of a medical procedure in a medicalfacility and for detecting fraud in reporting the consumption of themedial items, wherein the medical items are at least initially enclosedin wrappers having RFID tags disposed in or on the wrappers, wherein aunique identification number that uniquely identifies an individualmedical item is encoded in each of the RFID tags, the apparatuscomprising: a database in which are stored: Unique Device Identifier(UDI) numbers assigned by a governmental agency to identify specifictypes of medical items used in medical procedures; and uniqueidentification numbers encoded in the RFID tags, wherein each uniqueidentification number is stored in the database in association with oneof the UDI numbers that identifies the specific type of medical itemidentified by the unique identification number; a shielded enclosurehaving an internal space for receiving the wrappers of the medicalitems, the shielded enclosure configured to attenuate radio frequencysignals emanated from RFID tags disposed outside the shielded enclosureto levels that are substantially undetectable within the internal space;one or more RFID antennas disposed within the shielded enclosure forreceiving radio frequency signals emanated from RFID tags attached tothe wrappers disposed within the internal space, wherein the radiofrequency signals contain the unique identification numbers encoded inthe RFID tags; an RFID reader electrically connected to the one or moreRFID antennas, the RFID reader for decoding the unique identificationnumbers contained in the radio frequency signals emanated from the RFIDtags; and a computer disposed in the medical facility that is incommunication with the database and the RFID reader, the computer havinga processor that executes instructions for: (a) receiving the uniqueidentification numbers decoded by the RFID reader; (b) upon receipt ofthe unique identification numbers decoded by the RFID reader, accessingthe UDI numbers and the unique identification numbers stored in thedatabases; (c) generating a fraud alert message if any of the uniqueidentification numbers decoded by the RFID reader for each medical itemis not associated in the database with a UDI number assigned to identifythe specific type of medical item identified by the uniqueidentification number; and (d) generating a fraud alert message if anyunique identification number decoded by the RFID reader matches a uniqueidentification number stored in the database in association with amedical item that was previously consumed in medical treatment of apatient.
 2. The apparatus of claim 1 further comprising a waste bin thatis disposable within the internal space of the shielded enclosure, thewaste bin having an open top for receiving the used wrappers that aredropped into the waste bin during performance of the medical procedure.3. The apparatus of claim 2 wherein the shielded enclosure includes adoor in a sidewall of the shielded enclosure, the door covering anopening that is large enough to accommodate the waste bin.
 4. Theapparatus of claim 3 wherein: the shielded enclosure includes a switchdisposed adjacent the door, such that opening or closing the doorengages the switch to cause a change in state of the switch; and theRFID reader is electrically connected to the switch, wherein a change instate of the switch triggers the RFID reader to start or stop decodinginformation contained in the radio frequency signals emanated from theRFID tags.
 5. The apparatus of claim 1 wherein the shielded enclosureincludes an aperture through which the used wrappers may be depositedinto the internal space as medical items are consumed during performanceof the medical procedure, the aperture including means for attenuatingradio frequency signals emanated from RFID tags disposed outside theshielded enclosure to levels that are substantially undetectable withinthe internal space.
 6. The apparatus of claim 5 wherein the means forattenuating radio frequency signals emanated from RFID tags disposedoutside the shielded enclosure comprise one or more covers disposed overthe aperture.
 7. A method for recording consumption of medical itemsused during performance of a medical procedure and for detecting fraudin reporting the consumption of the medial items, wherein the medicalitems are at least initially enclosed in wrappers having RFID tagsdisposed in or on the wrappers, wherein a unique identification numberthat uniquely identifies an individual medical item is encoded in eachof the RFID tags, the apparatus comprising: (a) storing in a database:Unique Device Identifier (UDI) numbers assigned by a governmental agencyto identify specific types of medical items used in medical procedures;and unique identification numbers encoded in the RFID tags, wherein eachunique identification number is stored in the database in associationwith one of the UDI numbers that identifies the specific type of medicalitem identified by the unique identification number; (b) during theperformance of the medical procedure, depositing the wrappers of themedical items into an internal space of a shielded enclosure that isconfigured to attenuate radio frequency signals emanated from RFID tagsdisposed outside the shielded enclosure to levels that are substantiallyundetectable within the internal space; (c) receiving radio frequencysignals emanated from RFID tags attached to the wrappers disposed withinthe internal space, wherein the radio frequency signals contain theunique identification numbers encoded in the RFID tags; (d) decoding theunique identification numbers contained in the radio frequency signalsemanated from the RFID tags; (e) accessing the UDI numbers and theunique identification numbers stored in the database; (f) generating afraud alert message if any of the unique identification numbers decodedfrom the radio frequency signals is not associated with a UDI numberassigned to identify the specific type of medical item identified by theunique identification number; and (g) generating a fraud alert messageif any of the unique identification numbers decoded from the radiofrequency signals matches a unique identification number stored in thedatabase in association with a medical item that was previously consumedduring medical treatment of a patient.
 8. The method of claim 7 whereinsteps (e), (f) and (g) are performed by a computer that is disposed inthe medical facility and is in electrical communication with the RFIDreader, and wherein steps (e), (f) and (g) are performed automaticallyupon completion of step (d).
 9. The method of claim 7 wherein steps (e),(f) and (g) are performed by a computer that is used by a medical billpayer entity that receives a bill listing the unique identificationnumbers decoded by the RFID reader, and wherein steps (e), (f) and (g)are performed upon entry into the computer of the unique identificationnumbers listed in the bill.
 10. An apparatus for recording consumptionof medical items used during performance of a medical procedure in amedical facility and for detecting fraud in reporting the consumption ofthe medial items, wherein the medical items are at least initiallyenclosed in wrappers having RFID tags disposed in or on the wrappers,wherein a unique identification number that uniquely identifies anindividual medical item is encoded in each of the RFID tags, theapparatus comprising: a database in which are stored: Unique DeviceIdentifier (UDI) numbers assigned by a governmental agency to identifyspecific types of medical items used in medical procedures; and uniqueidentification numbers encoded in the RFID tags, wherein each uniqueidentification number is stored in the database in association with oneof the UDI numbers that identifies the specific type of medical itemidentified by the unique identification number; a shielded enclosurehaving an internal space for receiving the wrappers of the medicalitems, the shielded enclosure configured to attenuate radio frequencysignals emanated from RFID tags disposed outside the shielded enclosureto levels that are substantially undetectable within the internal space;one or more RFID antennas disposed within the shielded enclosure forreceiving radio frequency signals emanated from RFID tags attached tothe wrappers disposed within the internal space, wherein the radiofrequency signals contain the unique identification numbers encoded inthe RFID tags; an RFID reader electrically connected to the one or moreRFID antennas, the RFID reader for decoding the unique identificationnumbers contained in the radio frequency signals emanated from the RFIDtags; and a computer used by a medical bill payer entity, the computerin communication with the database and having a processor that, uponentry into the computer of the unique identification numbers listed inthe bill, executes instructions for: (a) accessing the UDI numbers andthe unique identification numbers stored in the database; (b) generatinga fraud alert message if any of the unique identification numbersdecoded by the RFID reader for each medical item is not associated witha UDI number assigned to identify the specific type of medical itemidentified by the unique identification number; and (c) generating afraud alert message if any unique identification number decoded by theRFID reader matches a unique identification number stored in thedatabase in association with a medical item that was previously consumedin medical treatment of a patient.